Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients With Type 2 Diabetes Mellitus on Stable Metformin Treatment
The primary aim of this exploratory mechanistic study is to investigate the effects of
Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.
This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to
placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell
function, as well as several markers of metabolic control.
This study will be performed as a multi-center study which includes 2 centres. 44 subjects
with T2DM are to be included according to the defined in- and exclusion criteria.
Subjects has to be on a stable metformin therapy and will receive in a first step
empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued
for another 30 days and subjects will be randomized to receive in addition Linagliptin or
Placebo for 30 days.
Subjects will come for two inhouse periods to their corresponding study center and will
undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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